Moldable Earpiece System

ABSTRACT

An earpiece including an external surface having a first fixed configuration disposable within the outer ear and having a passage adapted for retention of an in ear device a portion of which extends outwardly to releasably couple to an earplug adjacent the earpiece, the earpiece heatable to achieve a moldable condition which allows reconfiguration of the external surface by engagement with the outer ear to dispose the external surface in a second fixed configuration in greater conformity to the outer ear.

This United States Non-Provisional Patent Application is acontinuation-in-part of U.S. Ser. No. 13/761,947, filed Feb. 7, 2013which claims the benefit of U.S. Provisional Patent Application No.61/596,567, filed Feb. 8, 2012, each hereby incorporated by reference inthe entirety herein.

I. TECHNICAL FIELD

An earpiece including an external surface having a first fixedconfiguration disposable within the outer ear and having a passageadapted for retention of an in-ear device. The earpiece in the firstfixed configuration heatable to achieve a moldable condition whichallows reconfiguration of the external surface by engagement with theouter ear of a wearer to dispose the external surface in a second fixedconfiguration in greater conformity to the outer ear. The in-ear devicecan be retained in the passage of the earpiece in the second fixedconfiguration with a portion of the in-ear device extending outward ofthe earpiece to releasably couple to an earplug having a soundattenuation portion configured to conformably engage the ear canal wall.The earplug conformably engaged with the ear canal wall and the earpiecein the second fixed configuration engaged with the outer ear provides abarrier between the ear canal and the ambient environment to attenuatesound from the ambient environment.

II. BACKGROUND

A wide variety of apparatus which deliver sound to the ear such asmedical equipment, headsets, hearing aids, cellular telephones, and thelike include in part in-ear devices such as earphones, earplugs,earbuds, ear tips, ear tubes, or the like which are not configured tothe outer ear of the individual wearer.

Because conventional in-ear devices are not configured to the individualwearer's outer ear, the in-ear device may not stay in fixed engagementwith the outer ear, or the in-ear device may not align with the outerportion of the ear canal, or the in-ear device may be uncomfortable forthe wearer to insert into or retain in the ear.

The instant invention provides a moldable earpiece which retainsconventional in ear devices to overcome in whole or in part certain ofthe forgoing disadvantages associated with conventional in-ear devices.

III. SUMMARY OF THE INVENTION

Accordingly, a broad object of the invention can be to provide amoldable earpiece which includes an external surface disposed in a firstfixed configuration disposable within the outer ear of an ear of awearer and having a passage adapted for retention of an in-ear devicewhich upon heating to a moldable condition allows reconfiguration of theexternal surface by engagement with the outer ear of a wearer and uponcooling disposes the external surface of the earpiece in a second fixedconfiguration having greater conformity with the outer ear of the wearerand which retains the in-ear device in the passage of the earpiece inthe second fixed configuration with a portion of the in-ear deviceextending outward of the earpiece to releasably couple to an earplughaving a sound attenuation portion configured to conformably engage theexternal ear canal wall.

Another broad object of the invention can be to provide a method ofmaking a moldable earpiece for retention of an in-ear device whichincludes forming an earpiece to dispose the external surface in a firstfixed configuration disposable within the outer ear of an ear andproviding a passage adapted for retention of an in-ear device, theearpiece capable upon heating of achieving a moldable condition whichallows reconfiguration of the external surface of the earpiece byengagement with an outer ear of an ear and upon cooling disposes theexternal surface in a second fixed configuration having greaterconformity with the outer ear, the earpiece in the second fixedconfiguration capable of retaining the in-ear device in the passage ofthe earpiece with a portion of the in-ear device extending outward ofthe earpiece for releasable coupling of an earplug having a soundattenuation portion configured to conformably engage the ear canal wall.

Another broad object of the invention can be to provide a kit forproduction of an earpiece which retains an in-ear device and which hasgreater conformity with the wearer's outer ear, the kit including: amoldable earpiece having a passage adapted for retention of an in-eardevice, the earpiece upon heating to a moldable condition allowsreconfiguration of the external surface by engagement with the wearer'souter ear and upon cooling disposes the external surface in a secondfixed configuration having greater conformity to the wearer's outer ear;an in-ear device configured to be releasably retained in the passagewith a portion of the in-ear device extending outward of the earpiece;and an earplug which releasably couples to the portion of the in-eardevice extending outward of the earpiece adjacent the earpiece, theearplug having a sound attenuation portion configured to conformablyengage the ear canal wall concurrent with engagement of the earpiece inthe second fixed configuration with the outer ear.

Another broad object of the invention can be to provide a method ofmolding an earpiece which retains an in-ear device by obtaining anmoldable earpiece having an external surface disposed in a first fixedconfiguration disposable within the outer ear of an ear and having apassage adapted for releasable retention of the in-ear device and whichby heating the earpiece to achieve a moldable condition allowsreconfiguration of the external surface by engagement with the outer earof the ear and by cooling the earpiece while engaged with the outer eardisposes the external surface in a second fixed configuration havinggreater conformity with the outer ear which releasably retains thein-ear device with a portion of the in-ear device extending outward ofthe earpiece allowing releasable coupling of the earplug with theportion of the in-ear device extending outward of the earpiece.

Naturally, further objects of the invention are disclosed throughoutother areas of the specification, drawings, photographs, and claims.

IV. A BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is side perspective view which illustrates a step of a particularmethod of using an embodiment of the inventive earpiece in a first fixedconfiguration with a particular in-ear device in the form of an earspeaker.

FIG. 2 is front perspective view which illustrates a step of aparticular method of using an embodiment of the inventive earpiece in afirst fixed configuration with the particular in-ear device shown inFIG. 1.

FIG. 3 is a front view which illustrates a step of a method of using anembodiment of the inventive earpiece in a second fixed configurationengaged to the particular in-ear device shown in FIG. 1.

FIG. 4 is a top perspective view which illustrates a step of a method ofusing an embodiment of the inventive earpiece with a particular in-eardevice which is part of an apparatus which resides outside the ear inthe form of a hands free head set.

FIG. 5 is a top view which illustrates a step of a method of using anembodiment of the inventive earpiece in a first fixed configurationengaged to the particular in-ear device shown in FIG. 4.

FIG. 6 is a front view which illustrates a step of a method of using anembodiment of the inventive earpiece in a second fixed configurationengaged to the particular in-ear device shown in FIG. 4.

FIG. 7 is a cross section 7-7 of the particular earpiece shown in FIG.2.

FIG. 8 is cross section 8-8 having the particular earpiece shown inFIGS. 2 and 7 engaged with the in-ear device shown in FIG. 7.

FIG. 9 is an exploded perspective side view of a particular embodimentof the inventive earpiece in a first fixed configuration having apassage into which a conduit removably inserts to provide an internalsurface configured to retain an in ear device.

FIG. 10 is a top view of a particular embodiment of the inventiveearpiece in a first fixed configuration.

FIG. 11 is a bottom view of a particular embodiment of the inventiveearpiece in a first fixed configuration.

FIG. 12 is a front view of a particular embodiment of the inventiveearpiece in a first fixed configuration.

FIG. 13 is a back view of a particular embodiment of the inventiveearpiece in a first fixed configuration.

FIG. 14 is a first side view of a particular embodiment of the inventiveearpiece in a first fixed configuration.

FIG. 15 is a second side view of a particular embodiment of theinventive earpiece in a first fixed configuration.

FIG. 16 is cross section view 16-16 as shown in FIG. 9.

FIG. 17 is a cross section view 17-17 as shown in FIG. 12.

FIG. 18 is front view of the embodiments of the earpiece shown in FIGS.10 through 17 and 19 through 28 in a second fixed configuration engagedwithin the outer ear and retaining a particular embodiment of an in-eardevice.

FIG. 19 is an exploded view of an embodiment of the earpiece in a firstfixed configuration including a conduit having an external surfaceconnected to the earpiece and an internal surface defining a passage inwhich the in-ear device is releasably retained with a portion extendingoutward of the earpiece which couples to an earplug.

FIG. 20 is a cross section view of the ear which shows an embodiment ofthe earpiece of FIG. 27 in a second fixed configuration of the earpiecewith the earplug conformed to the ear canal wall.

FIG. 21 is a top view of an embodiment of the earpiece in the firstfixed configuration.

FIG. 22 is a bottom view of an embodiment of the earpiece in the firstfixed configuration.

FIG. 23 is a first side view of an embodiment of the earpiece in thefirst fixed configuration.

FIG. 24 is a first end view of an embodiment of the earpiece in thefirst fixed configuration.

FIG. 25 is a second end view of an embodiment of the earpiece in thefirst fixed configuration.

FIG. 26 is a second side view of an embodiment of the earpiece in thefirst fixed configuration.

FIG. 27 is an exploded cross section view 20-20 of the exploded view ofthe embodiment shown in FIG. 19.

FIG. 28 is an enlarged a cross section view 20-20 of the assembled viewof the embodiment shown in FIG. 20.

FIG. 29 is a front perspective view of a particular embodiment of theearpiece in a first fixed configuration having a conduit which extendsoutwardly to couple to an speaker tube of an apparatus worn outside theear in the form of a hearing aid.

FIG. 30 is a front view of the embodiment of the earpiece in a secondfixed configuration engaged within the outer ear and retaining thespeaker tube shown in FIG. 19 of the hearing aid worn outside the ear.

FIG. 31 is a front perspective view of an embodiment of the earpiece ina first fixed configuration adapted to retain a particular embodiment ofan in ear device in the form of an in ear hearing aid.

FIG. 32 is a front view of the embodiment of the earpiece shown in FIG.21 in a second fixed configuration engaged within the outer ear andretaining the in ear hearing aid as shown in FIG. 21.

FIG. 33 is a cross section view of the ear which shows an embodiment ofthe earpiece in a second fixed configuration adapted to retain aparticular embodiment of an in ear device in the form of an in ear canalhearing aid.

FIG. 34 is a block flow diagram of a method of providing a kit for anembodiment of a moldable earpiece system.

FIG. 35 is a block flow diagram of a method of sculpting an embodimentof a moldable earpiece system.

V. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Generally referring to FIGS. 1 through 8, which illustrate a genericembodiment of an inventive moldable earpiece (1)(also referred to as an“earpiece”) having an external surface (2) disposed in a first fixedconfiguration (3) disposable within the outer ear (4) of an ear (5). Theearpiece (1) having a passage (6) which communicates between a firstlocation (7) and a second location (8) on the external surface (2) ofthe earpiece (1) and adapted for retention or releasable retention of anin ear device (9) in the earpiece (1). The earpiece (1) can be heated toachieve a moldable condition (10) which allows reconfiguration of theexternal surface (2) by engagement within the outer ear (4) and can becooled while engaged with the outer ear (4) to dispose the externalsurface (2) in a second fixed configuration (11) conformed more closelyto the configuration of the outer ear (4). As to particular embodiments,the earpiece (1) can be provided separate from but capable of use withone or more of a wide variety of in-ear devices (9), for example:earphones, earplugs, earbuds, ear tips, ear tubes, ear speakers, and inear hearing aids, or the like. As to particular embodiments, the in-eardevices (9) can be a part of an apparatus (57) worn or which residesoutside of the ear (5), for example: headsets, head phones, telephones,blue tooth headphones, wireless headphones, hearing aids, medicalapparatus, or the like. As to other embodiments, the earpiece (1) andthe in-ear device (9) can be provided in combination as part of amoldable earpiece system (12) or the earpiece (1) can be provided aspart of a kit (13) which can be used by a wearer (14) for production ofan earpiece (1) having greater conformity with the wearer's (14) outerear (4) for retention or releasable retention of an in-ear device (9).

Embodiments of the moldable earpiece (1) having an external surface (2)disposed in the first fixed configuration (3) can be formed from anamount of moldable material (15). The term “moldable material” means forthe purpose of this invention any material which retains a fixedconfiguration disposable within the outer ear (also referred to as the“first fixed configuration” (3)) at temperatures below about 40° C.(110° F.) and achieves a moldable condition (10) in a temperature rangeof about 40° C. (about 110° F.) and about 65° C. (150° F.) which allowsthe external surface (2) of the earpiece (1) to be reconfigured byengagement with the outer ear (4) and allows the passage (6) to bereconfigured by engagement with an in ear device (9) with the materialremaining moldable at temperatures sufficiently low to avoid injury tothe outer ear (4) or damage to the in-ear device (9) and which cures atambient temperature or while engaged with the outer ear (4) to retain afixed configuration conformed more closely to the configuration of theouter ear (4) (also referred to as the “second fixedconfiguration”(11)).

The amount of moldable material (15) can be one or more of, combinationsof, or admixtures of one or more thermoplastic polymers suitable for usewith the invention, such as: polyethylene, polypropylene, polyvinylchloride (PVC), polystyrene, polyester, polycaprolactone,polytetrafluoroethylene, acrylonitrile butadiene styrene, or the like.

As one illustrative example, embodiments of the earpiece (1) can beformed from an amount of polycaprolactone polymer (CAS No.: 24989-41-4);however, other thermoplastic polymers suitable for use with embodimentsof the invention can have physical properties as those described inTable 1 for polycaprolactone polymer, or similar physical propertieswhich allow the material to be utilized in one or more of theembodiments of the earpiece (1).

TABLE 1 Physical Properties of Polycaprolactone Thermoplastic PolymersPhysical Property ASTM Test Molecular Weight Mn GPC, THF, 25° C. 37,000± 2000; 47500 ± 2000;  69000 ± 1500 Mw GPC, THF, 25° C.  84500 ± 1000;120000 ± 2000 Mz GPC, THF, 25° C. 130000 ± 5000; 178500 Polydispersity(Mw/Mn) 1.78 1.74 Melt Flow Index D 1238 80° C., 2.16 kg, g/10 min 2.360.59 80° C., 21.6 kg, g/10 min 34.6 9.56 190° C., 2.16 kg, g/10 min 287.29 Thermal Analysis (DSC) Melting Point ° C. 60-62 60-62 Heat OfFusion, DHm, J/g 76.9 76.6 Crystallinity, % 56 56 CrystallisationTemperature, ° C. 25.2 27.4 Glass Transition Temperature, Tg, ° C. −60−60 Tensile Properties Yield Stress, s y, Mpa D 412-87 100 mm/min 17.516 500 mm/min 17.2 14 Modulus, E. Mpa D 412-87 1 mm/min 470 440 10mm/min 430 500 Draw Stress, s d, MPa D 412-87 100 mm/min 12.6 11.9 500mm/min 11.5 11 Draw Ratio, 1 d, x D 412-87 100 mm/min >4.2 4 Stress AtBreak, s b, Mpa D 412-87 100 mm/min 29 54 Strain At Break, e b, % 100mm/min D 412-87 >700 920 Flexural Modulus, E, MPa 2 mm/min D 790 411 ndHardness D 2240 Shore A 95 94 Shore D 51 50 Viscosity Pa. sec, 70° C.,10 1/sec 2890 12650 Pa. sec, 100° C., 10 1/sec 1353 5780 Pa. sec, 150°C., 10 1/sec 443 1925

As to the illustrative example, polycaprolactone polymers provide abiodegradable polyester with a molecular weight in the range of 37,000grams per mole and 80,000 grams per mole each having a melting point ofabout 60° C. useful in making and using embodiments of the earpiece (1).Polycaprolactone polymers impart good water, oil, solvent, and chlorineresistance. Polycaprolactone polymers are also compatible with widerange of other materials (collectively referred to as “admixed agents”(38)), such as: starch to impart greater biodegradability; colorants,such as alcohol dyes or acrylic coloring agents; powders such as acrylicpowder; particulates of plastic, copolymer plastics, metal, bismuthoxychloride, or glitter; or the like, either separately or in variouscombinations. Polycaprolactone polymers are non-toxic and approved bythe United States Food and Drug Administration for specific applicationsin the human body.

The term “outer ear” for the purposes of this invention includes thevisible part of the ear that resides outside of the head (16) (alsoreferred as the “auricle”) which in part includes the outer ear bowl(17) and the outer portion of the open ear canal (18) (also referred toherein as the “concha”) having skin that moves with that of the outerear bowl (17)(as shown in the example of FIG. 2).

The term “ear canal” for the purposes of this invention includes (58)from the outer portion of the open ear canal (18) to the ear drum (80).

Now referring primarily to FIGS. 1 through 18, particular embodiments ofthe earpiece (1) can be formed from an amount of moldable material (15)to provide an external surface (2) disposed in a first fixedconfiguration (3) disposable in the outer ear (4). The first fixedconfiguration (3) can provide a first portion (19) of the externalsurface (2) configured to allow or facilitate engagement with a part ofthe outer ear (4). As illustrative examples, embodiments can have thefirst portion (19) of the external surface (2) configured generally as ahemisphere (as shown in the examples of FIGS. 1, 2, 4 and 5) orconfigured generally in droplet shape or comma shape (as shown in theexample of FIGS. 10 through 15) or configured as a truncated cone (asshown in the examples of FIGS. 19 and 21); however, as to otherembodiments, the first portion (19) of the external surface (2) can beconfigured in any other configuration which facilitates engagement ofthe earpiece (1) in the first fixed configuration (3) with a part of theouter ear (4), the outer ear bowl (17), or the outer portion of the earcanal (18).

The remaining second portion (20) of the external surface (2) can beformed in the first fixed configuration (3) to provide a generally flatsurface (as shown in the examples of FIGS. 1, 2, 4, 5, 7, 8, 12, 19 and21); although the second portion (20) of the external surface (2) in thefirst fixed configuration (3) can be configured in any form which allowsthe passage (6) adapted for retention or releasable retention of the inear device (9) to communicate between a first location (7) and a secondlocation (8) on said external surface (2) of said earpiece (1).

Now referring primarily to FIGS. 7, 8 and 17, the passage (6) whichcommunicates between a first location (7) on the first portion (19) anda second location (8) on the second portion (20) of the external surface(2) and can be configured to receive the in ear device (9) at a locationwithin the passage (6) to position a sound delivery element (21)proximate the first location (7) of the external surface (2) of theearpiece (1) and position the body (22) of the in ear device (9)proximate the second location (8) of the external surface (2). Thepassage (6) can be configured in a wide variety of structural forms toreceive a correspondingly wide variety of structural forms of the in eardevice (9). As shown in the example of FIGS. 7 and 8, where the in eardevice (9) has a generally cylindrical structure, the passage (6) candefine a corresponding generally cylindrical volume, or as further shownin the example of FIGS. 7 and 8 where the body (22) of the in ear device(9) has a greater diameter than the sound delivery element (21) thepassage (6) can corresponding provide a first passage portion (23) ofgreater diameter than a second passage portion (24) for retention orreleasable retention of the in ear device (9) within the passage (6).The earpiece (1) can have an external surface (2) in the first fixedconfiguration (3) which engaged with the outer ear (4) substantiallyaligns the passage (6) with the ear canal (18).

Now referring primarily to FIGS. 9 through 18, embodiments of theinventive earpiece (1) can further include a conduit (25) which definesthe passage (6) which communicates between the first location (7) andthe second location (8) on said external surface (2) of the earpiece(1). The conduit (25) can have a conduit external surface (26) whichengages the moldable material (15) of the earpiece (1) and a conduitinternal surface (27) which defines a configuration of the passage (6)adapted for retention or releasable retention of the in ear device (9)in the earpiece (1). The configuration of the conduit internal surface(27) of the conduit (25) can vary between embodiments to retain orreleasably retain a wide variety of configurations of the in ear device(9).

As to particular embodiments, the conduit (25) can take the form of anelastomer layer (28) formed integral with the amount of moldablematerial (15) to provide a one-piece conduit earpiece (1)(as shown inthe examples of FIGS. 10 through 11) with the elastomer layer (28)providing the conduit internal surface (27) defining the configurationof the passage (6)(as shown by the example shown in FIG. 17).

As to other particular embodiments, the conduit (25) can take the formof a flexible elastomer insert (29) which removably couples within thepassage (6) the earpiece (1) with the the flexible elastomer insert (29)providing the conduit internal surface (26) defining the configurationof the passage (6) to retain or releasable retain the in ear device (9)in the earpiece (1). A plurality of flexible elastomer inserts (28) eachhaving substantially the same configuration of the conduit externalsurface (26) can provide a plurality of different configurations of theconduit internal surface (27) to retain or releasably retain acorresponding plurality of different configurations of the in ear device(9) by interchanging the conduit (25) removably coupled within thepassage (6) to provide in one earpiece (1) a plurality of differentconfigurations of the conduit internal surface (27).

Additionally, the conduit (25) can be provided with sufficientstructural rigidity to maintain the configuration of the passage (6) forretention or releasable retention of the in ear device (9) even in themoldable condition (10) of the earpiece (1).

Now referring primarily to FIGS. 19 through 28, as to particularembodiments of the moldable earpiece (1), the earpiece (1) can have apassage (6) which communicates between a first location (7) and a secondlocation (8) on the external surface (2) of the earpiece (1) (as shownin the illustrative example of FIGS. 21 through 26 the passagecommunicates between opposed faces (61)(62) of the earpiece (1) in thefirst fixed configuration (3)). The passage (6) can be configured toreleasably retain an in-ear device (9) in the passage (6) with a portion(63) of the in-ear device (9) extending outwardly from the earpiece (1)for insertion into the ear canal (58) of the ear (4) (as shown in theillustrative example of FIG. 20). An earplug (64) can be coupled ordirectly coupled to the portion (63) of the in-ear device (9) extendingfrom the earpiece (1) (as shown in the illustrative examples of FIGS. 20and 28). The earplug (64) can have an earplug external surface (65)configured to engage the ear canal wall (68) defining the ear canal(58)(as shown in the illustrative example of FIG. 20).

Now referring primarily to FIGS. 19, 26 and 27, an illustrative exampleof an earplug (64) suitable for use with embodiments of the inventionincludes an elongate tubular core (66) defining an earplug passage (79)through which the portion (63) of the in-ear device (9) extendingoutward from the earpiece (1) passes to couple or directly couple theearplug (64) to the in-ear device (9) with the earplug (64) positionedadjacent the earpiece (1)(as shown in the example of FIG. 28) and canfurther include a sound attenuating portion (67) connected or directlyconnected to the elongate tubular core (66). The sound attenuatingportion (63) can be configured to conformably engage the ear canal wall(68) of the ear (4). While the illustrative example of the ear plug (64)includes a sound attenuating portion (67) having at least one flexibleconvex annular member (69) having an internal concentric edge (70)circumferentially joined to the elongate tubular core (66) and with theflexible convex annular member (69) outwardly radially extending fromthe elongate tubular core (65) to terminate at an external concentricedge (71); however, it is not intended that the earplug (64) beconfigured solely in this structural form. Rather, the illustrativeexample is intended to enable a person of ordinary skill in the art tomake and use a wide variety of earplugs (65) that can be coupled,directly coupled or joined to the portion (63) of an in-ear device (9)extending outward of the earpiece (1) which can be inserted into the earcanal (58) to conformingly engage with the ear canal wall (68) of theear (4) to act as a barrier between the ear canal (58) and the ambientenvironment (72) outside of the ear (4) to attenuate or reduce sound(73) from the ambient environment (72) transmitted to the ear canal(58). Accordingly, the earplug (65) can be made from a wide variety ofconforming structures or conforming materials such as a resilientcompressible material having a first structural condition which uponapplication of force assumes a second structural condition having areduced volume and upon release of applied force returns toward thefirst structural condition, such as compressible foam, sponge, glassdown, or the like.

As to particular embodiments of the sound attenuating portion (67) ofthe earplug (64), the at least one flexible convex annular member (69)comprises a pair of flexible convex annular members (69)(74) having acorresponding pair an internal concentric edges (70)(75)circumferentially joined in spaced apart relation along the elongatetubular core (66). The pair of flexible convex annular members (69)(74)can each outwardly radially extend from said elongate tubular core (66)to terminate at a corresponding pair of external concentric edges(71)(76) with a first one of the pair of external concentric edges (71)having a lesser diameter (77) than the second one of the pair ofexternal concentric edges (76) which has a greater diameter (78). Whilethe illustrative example of the earplug (64) shown in FIGS. 19, 26, and27 has a pair of flexible convex annular members (69)(74); this is notintended to necessarily limit embodiments to a pair of flexible convexmembers (69)(70). Rather embodiments of the earplug (64) can have one,two, three, or more flexible convex annular members depending upon theapplication.

Now referring primarily to FIGS. 20 through 25, particular embodimentsof the invention can further include a conduit (25) which communicatesbetween a first location (7) and a second location (8) on said externalsurface (2)(or opposed faces (61)(62)) of the earpiece (1)(as shown inthe illustrative examples of FIGS. 23 and 26). The conduit (25) can havea conduit external surface (26) which connects or directly connects tothe earpiece (1) and an conduit internal surface (27) which defines thepassage (6) through which the in-ear device (9) passes (as shown in theillustrative examples of FIGS. 19 through 28). The conduit internalsurface (27) can be configured to releasably retain the in-ear device(9) in the passage (6) with the portion (23) of the in-ear device (9)extending outward from the earpiece (1) (as shown in the illustrativeexamples of FIGS. 27 and 28). As to particular embodiments, the conduit(25) and the earpiece (1) can be molded as one piece with the earpiece(1) having an external surface (2) disposed in a first fixedconfiguration (3)(as shown in the examples of FIGS. 21 through 26). Thefirst fixed configuration (3) can be disposable within the outer ear (4)of an ear (5) to facilitate reconfiguration of the earpiece (1) in themoldable condition (10) by engagement with the outer ear (4), as abovedescribed.

As to the particular embodiments shown in FIGS. 21 through 26, theconduit (25) can be made of a material sufficiently rigid attemperatures which achieve the moldable condition (10) of the earpiece(1) (between about 40° C. (about 110° F.) and about 65° C. (150° F.)) toretain the configuration of the conduit internal surface (27), therebyallowing the earpiece (1) to achieve the moldable condition (10) andallow reconfiguration of the external surface (2) by engagement withsaid outer ear (4) without deforming the conduit internal surface (27)or altering the open space within the passage (6). Accordingly, afterthe earpiece (1) cools while engaged with the outer ear (4) disposingthe external surface (2) in the second fixed configuration (11), theconduit internal surface (27) remains configured to realeasably retainthe in-ear device (9) and allow coupling of the earplug (64) to theportion (23) extending beyond the earpiece (64), as above described.

Now referring primarily to FIG. 28, the earpiece (1) in the second fixedconfiguration (11) having the in-ear device (9) retained within theconduit (25) and having the earplug (64) coupled to the portion (23) ofthe in-ear device (9) extending outward of the earpiece (1) can beinserted into the ear (5) of the wearer (14) to engage the earpiece (1)in the second fixed configuration (11) with the outer ear (4) and havingthe earplug (64) conformably engaged with the ear canal wall (68).

Now referring primarily to FIGS. 29 and 30, particular embodiments ofthe conduit (25) can be configured to extend outwardly from the earpiece(1) to couple to a speaker tube (30) (also referred to as “hearing aidtube”) of a hearing aid (31) worn outside of the ear (5) (or couple to asimilar sound conveyance structure). The earpiece (1) can be configuredas above described to provide an external surface (2) formed in a firstfixed configuration (3). The earpiece (1) can be heated to achieve themoldable condition (10) of the external surface (3) which can be engagedto the outer ear (4) and cooled to provide the second fixedconfiguration (11) of the earpiece (1) with the conduit (25) extending asufficient distance outward of the second portion (20) of the externalsurface (3) to couple the speaker tube (30)(as shown in the example ofFIG. 20).

Now referring primarily to FIGS. 31 and 32, a similar embodiment of theearpiece (1) provide an external surface (2) formed in the first fixedconfiguration (3)(as shown in the example of FIG. 21) having a passage(6) configured to retain or releasably retain an in ear device (9) inthe form of an in ear hearing aid (31). The earpiece (1) can be heatedto achieve the moldable condition (10) of the external surface (2) whichcan be engaged to the outer ear (4) and cooled to provide the secondfixed configuration (11) of the earpiece (1) with the passage (6), orthe conduit (25) having a conduit internal surface (27) defining theconfiguration of the passage (6), which retains or releasably retainsthe in-ear hearing aid (31)(as shown in the example of FIG. 22).

Now referring primarily to FIG. 33, particular embodiments of theinvention having a first fixed configuration (3) similar to that shownin FIG. 21 can be utilized to retain an in ear canal hearing aid (59) asabove defined and as shown in FIG. 23. The particular embodiments of thefirst fixed configuration (3) utilized with in ear canal hearing aids(59) further include an earpiece withdrawal element (60) which can be inthe form of a stiff member or a flexible cord depending upon theapplication.

Now referring primarily to FIG. 34, embodiments of the invention canprovide a kit (13). The kit (13) can be produced by obtaining an amountof moldable material (15) (as shown in step (32)), having physicalproperties as or similar to those above described or useful in making orusing embodiments of the invention as described, such as apolycaprolactone polymer. The amount of moldable material (15) can besufficiently heated (as shown in step (33)) to allow, if desired,admixing of one or more admixed agents (38) (as shown in step (34)) toalter one or more physical properties of the amount of moldable material(15) depending upon the application. The amount of moldable material(15) (whether or not, the amount of moldable material (4) includes oneor more admixed agents (38)) can be sufficiently heated in step (33) toallow molding of the earpiece (1) (whether in a mold (39) or otherwiseformed)(as shown in step (35)) having an external surface (2) in thefirst fixed configuration (3) disposable within the outer ear (4) of anear (5) and having a passage (6) which communicates between a firstlocation (7) and a second location (8) on the external surface (2) ofthe earpiece (1) for retention of an in ear device (9).

For example, polycaprolactone polymers can be obtained (step 32) andheated to about 65° C. (150° F.)(step 33) to allow admixing with one ormore admixed elements (6) (step 34) and molding an amount of thepolycaprolactone polymers in a mold (39) (step 35) to produce theearpiece (1) having an external surface in the first fixed configuration(3). The earpiece (3) can be cooled to room temperature (or below about40° C. (110° F.) to maintain the configuration imparted by the mold(39).

Production of the kit (13) can further include packaging of the earpiece(1) (as shown in step (36)) separate of any in-ear device (9) or incombination with an in-ear device (9). As to particular embodiments, thein-ear device (9) can be configured to be releasably retained within thepassage (6) with a portion (23) of the in-ear device (9) extendingoutward of the earpiece (1). The kit (13) can further include an earplug(64) configured to couple to the portion (23) of the in-ear device (9)and having an sound attenuation portion (67) configured to conformablyengage the ear canal wall (68)(as shown in the example of FIG. 28).Subsequent distributing of the kit (13) (as shown in step (37)) allows aplurality of earpiece wearers (14) access to a plurality of earpieces(1) having an external surface (2) that can be reconfigured from a firstfixed configuration (3) to a second fixed configuration (11) havinggreater conformity with the wearer's (14) outer ear (4) for retention orreleasable retention of an in-ear device (9).

Now referring primarily to FIG. 35, which provides block flow diagram ofusing embodiments of the inventive earpiece (1) whether or not obtainedas a kit (13), or whether obtained with or separate from an in eardevice (9). A first step includes obtaining an earpiece (1) having anexternal surface (2) disposed in a first fixed configuration (3)disposable within the outer ear (4) of an ear (5) and having a passage(6) which communicates between a first location (7) and a secondlocation (8) on the external surface (2) of the earpiece (1) and adaptedto retain or releasably retain an in ear device (9) in said earpiece (1)(as shown in step (40) and as shown in the examples of FIGS. 1, 2, 4, 7,10 through 17, 19, 26, 27 and 31).

A second step includes heating the earpiece (1) to achieve a moldablecondition (10) which allows reconfiguration of the external surface (2)(as shown in step 41). Heating to achieve the moldable condition (10) ofthe earpiece (1) as obtained in step (40) can be accomplished in avariety of ways. As a first illustrative example, the moldable earpiece(1) can be located in a heated enclosure (49). Where the earpiece (1) inthe first fixed configuration (3) is formed from polycaprolactone (orother material(s) have same or similar physical properties), themoldable earpiece (1) can be heated within the heated enclosure (49)having sufficient temperature to achieve the molded condition (10). Asto particular embodiments, the heated enclosure (49) can have atemperature maintained at about 70° C. (160° F.) and the earpiece (1)can be heated within the heated enclosure (49) for about 10 minutes. Themoldable earpiece (3) can be removed from the heated enclosure (49) andallowed to sufficiently cool for engagement with the outer ear (4)(typically about 30 seconds).

As a second illustrative example, the moldable earpiece (1) can belocated in an amount of liquid (50). The amount of liquid (50) can beany liquid which does not degrade the moldable material (15) of theearpiece (1) and which can hold a temperature sufficient to heat theearpiece (1) to achieve the moldable condition (10), such as an oil,alcohol, water, or the like, or combinations thereof. Typically, theamount of liquid (50) will be an amount of water (51). The amount ofliquid (50) can be sufficiently heated to achieve the moldable condition(10). For example, where the moldable earpiece (3) is made frompolycaprolactone polymer, the earpiece (1) can be heated in an amount ofwater (50) to a temperature of about 60° C. (140° F.) for about 5minutes. The earpiece (1) can be removed from the heated water (50) andallowed to sufficiently cool for engagement with the outer ear (4)(typically about 30 seconds). As to particular embodiments, the earpiece(1) in the first fixed configuration (3) of the external surface (2)disposed in the amount of liquid (50) can be heated by exposing theearpiece (1) disposed in said amount of liquid (50) to an amount ofmicrowave radiation (51) sufficient to achieve the moldable condition(10). As to particular embodiments, the earpiece (1) can be exposed toan amount of microwave radiation (51) sufficient to achieve the moldablecondition (10).

As a third illustrative example, the earpiece (1) can be located in aflow of heated fluid (52). The flow of heated fluid (52) can be a flowof heated air (53); although the invention is not so limited. As toparticular embodiments of the earpiece (3) made from polycaprolactonepolymer (or other material have the same or similar physicalproperties), a flow of sufficiently heated air (53) can be obtained fromconventional hair dryer (54). The settings of the hair dryer (55) as totemperature and flow rate can be adjusted to allow the earpiece (1) tobe sufficiently heated to achieve the moldable condition (10),typically, within a period of about one minute to about 2 minutes. Theearpiece (1) can be removed from the flow of heated air (53) and allowedto sufficiently cool for engagement with the outer ear (4) (typicallyabout 30 seconds). The above illustrative examples are not intended tobe limiting with respect to the method of heating the moldable earpiece(1) and other methods of heating the moldable earpiece (1) can beutilized, including, for example, a sand bath or salt bath.

Again referring primarily to FIG. 35, by disposing the in-ear device (9)into the passage (6) of the earpiece (1) in the moldable condition(10)(as shown in step 42 and as shown in the examples of FIGS. 5 and 8),the wearer (14) can forcibly urge the moldable material (15) of theearpiece (1) in contact with the in-ear device (9) to reconfigure thepassage (6) to retain or releasably retain the in-ear device (9) in theearpiece (1). As to particular embodiments, by disposing the in-eardevice (9) in a conduit (25) (as shown in the examples of FIGS. 17, 19,26 and 27) the wearer can maintain the configuration of the passage (6)defined by the conduit internal surface (27) to retain or releasablyretain the in-ear device (9) in the earpiece (1). As to particularembodiments, a portion (23) of the in-ear device (9) retained within thepassage (6) of the earpiece (1) in the second fixed configuration (11)can extend outwardly of the earpiece (1). The wearer (14) can couple anearplug (64) to the portion (23) of the in-ear device (9) extendingoutwardly of the earpiece (1).

Again referring primarily to FIG. 35, the earpiece (1) in the moldablecondition having the in-ear device (9) retained in the passage (6) canbe disposed in the outer ear (4) aligning the sound delivery element(21) of the in-ear device (9) with the outer portion of the ear canal(18)(as shown in step 43 and in the examples of FIGS. 2 and 5)compressibly conforming the earplug (64) to the ear canal wall (68). Theearpiece (1) engaged with the outer ear (4) and having the sounddelivery element (21) in alignment with the outer portion of the earcanal (18) with the earplug (64) conformingly engaged with the ear canalwall (68) can be molded (as shown in step (44)) by forcible urging ofthe fingers (56) to reconfigure the external surface (2) of the earpiece(1) to more closely conform to the engaged part of the outer ear (4) (asshown in the examples of FIGS. 3, 6, 18, 28, 30, and 32).

Again referring primarily to FIG. 35, once the earpiece (1) has beenmolded by engagement with the outer ear (4), the earpiece (1) engagedwith the outer ear (4) can be allowed to cool to ambient temperature, orsufficiently cool to achieve the second fixed condition (11) of theexternal surface (2) of the earpiece (1) which more closely conforms tothe engaged part of the outer ear (4) (as shown by step 45). Typically,sufficient cooling can be achieve in a period of about five minutes toabout ten minutes. Cooling allows the earpiece (1) to cure in a secondfixed configuration (11) which conforms to the outer ear (4) of thewearer (14). During the cooling, the wearer (14) should not talk orotherwise move the mouth or face. The earpiece (1) can then be removedfrom the out ear (4) of the wearer (14) (as shown as step (41)). Theearpiece (1) in the second fixed configuration (11) can be re-insertedinto the outer ear (4) and removed from the outer ear (4) as desired(shown as steps (46) and (47). Additionally, steps 41 through 46 can berepeated to re-configure the external surface of the earpiece (1).

As can be easily understood from the foregoing, the basic concepts ofthe present invention may be embodied in a variety of ways. Theinvention involves numerous and varied embodiments of a moldableearpiece (1) or moldable earpiece system (12) which can be utilized forthe production of a molded earpiece (56) by the process above described.

As such, the particular embodiments or elements of the inventiondisclosed by the description or shown in the figures or tablesaccompanying this application are not intended to be limiting, butrather exemplary of the numerous and varied embodiments genericallyencompassed by the invention or equivalents encompassed with respect toany particular element thereof. In addition, the specific description ofa single embodiment or element of the invention may not explicitlydescribe all embodiments or elements possible; many alternatives areimplicitly disclosed by the description and figures.

It should be understood that each element of an apparatus or each stepof a method may be described by an apparatus term or method term. Suchterms can be substituted where desired to make explicit the implicitlybroad coverage to which this invention is entitled. As but one example,it should be understood that all steps of a method may be disclosed asan action, a means for taking that action, or as an element which causesthat action. Similarly, each element of an apparatus may be disclosed asthe physical element or the action which that physical elementfacilitates. As but one example, the disclosure of “a moldable earpiece”should be understood to encompass disclosure of the act of “molding anearpiece”—whether explicitly discussed or not—and, conversely, werethere effectively disclosure of the act of “molding an earpiece”, such adisclosure should be understood to encompass disclosure of “a moldableearpiece” and even a “means for molding an earpiece.” Such alternativeterms for each element or step are to be understood to be explicitlyincluded in the description.

In addition, as to each term used it should be understood that unlessits utilization in this application is inconsistent with suchinterpretation, common dictionary definitions should be understood to beincluded in the description for each term as contained in the RandomHouse Webster's Unabridged Dictionary, second edition, each definitionhereby incorporated by reference.

Moreover, for the purposes of the present invention, the term “a” or“an” entity refers to one or more of that entity; for example, “a lightsource” refers to one or more of those light sources. As such, the terms“a” or “an”, “one or more” and “at least one” can be usedinterchangeably herein.

All numeric values herein are assumed to be modified by the term“about”, whether or not explicitly indicated. For the purposes of thepresent invention, ranges may be expressed as from “about” oneparticular value to “about” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueto the other particular value. The recitation of numerical ranges byendpoints includes all the numeric values subsumed within that range. Anumerical range of one to five includes for example the numeric values1, 1.5, 2, 2.75, 3, 3.80, 4, 5, and so forth. It will be furtherunderstood that the endpoints of each of the ranges are significant bothin relation to the other endpoint, and independently of the otherendpoint. The term “about” generally refers to a range of numeric valuesthat one of skill in the art would consider equivalent to the recitednumeric value or having the same function or result.

Similarly, the antecedent “substantially” means largely, but not wholly,the same form, manner or degree and the particular element will have arange of configurations as a person of ordinary skill in the art wouldconsider as having the same function or result. When a particularelement is expressed as an approximation by use of the antecedent“substantially,” it will be understood that the particular element formsanother embodiment.

Thus, the applicant(s) should be understood to claim at least: i) eachof the moldable earpieces herein disclosed and described, ii) therelated methods disclosed and described, iii) similar, equivalent, andeven implicit variations of each of these devices and methods, iv) thosealternative embodiments which accomplish each of the functions shown,disclosed, or described, v) those alternative designs and methods whichaccomplish each of the functions shown as are implicit to accomplishthat which is disclosed and described, vi) each feature, component, andstep shown as separate and independent inventions, vii) the applicationsenhanced by the various systems or components disclosed, viii) theresulting products produced by such systems or components, ix) methodsand apparatuses substantially as described hereinbefore and withreference to any of the accompanying examples, x) the variouscombinations and permutations of each of the previous elementsdisclosed.

The background section of this patent application provides a statementof the field of endeavor to which the invention pertains. This sectionmay also incorporate or contain paraphrasing of certain United Statespatents, patent applications, publications, or subject matter of theclaimed invention useful in relating information, problems, or concernsabout the state of technology to which the invention is drawn toward. Itis not intended that any United States patent, patent application,publication, statement or other information cited or incorporated hereinbe interpreted, construed or deemed to be admitted as prior art withrespect to the invention.

The claims set forth in this specification, if any, are herebyincorporated by reference as part of this description of the invention,and the applicant expressly reserves the right to use all of or aportion of such incorporated content of such claims as additionaldescription to support any of or all of the claims or any element orcomponent thereof, and the applicant further expressly reserves theright to move any portion of or all of the incorporated content of suchclaims or any element or component thereof from the description into theclaims or vice-versa as necessary to define the matter for whichprotection is sought by this application or by any subsequentapplication or continuation, division, or continuation-in-partapplication thereof, or to obtain any benefit of, reduction in feespursuant to, or to comply with the patent laws, rules, or regulations ofany country or treaty, and such content incorporated by reference shallsurvive during the entire pendency of this application including anysubsequent continuation, division, or continuation-in-part applicationthereof or any reissue or extension thereon.

The claims set forth in this specification, if any, are further intendedto describe the metes and bounds of a limited number of the preferredembodiments of the invention and are not to be construed as the broadestembodiment of the invention or a complete listing of embodiments of theinvention that may be claimed. The applicant does not waive any right todevelop further claims based upon the description set forth above as apart of any continuation, division, or continuation-in-part, or similarapplication.

1-14. (canceled)
 15. A method of making a moldable earpiece for anin-ear device, comprising: providing an earpiece having an externalsurface disposed in a first fixed configuration disposable within theouter ear of an ear, said earpiece heatable to achieve a moldablecondition which allows reconfiguration of said external surface byengagement with said outer ear, said earpiece coolable while engagedwith said outer ear to dispose said external surface in a second fixedconfiguration, said earpiece having a passage which communicates betweena first location and a second location on said external surface of saidearpiece, said passage adapted to releasably retain an in-ear device insaid passage.
 16. The method of claim 15, further comprising disposing aconduit within said earpiece which communicates between said firstlocation and said second location on said external surface of saidearpiece, said conduit having an internal surface which defines saidpassage adapted for releasable retention of said in ear device.
 17. Themethod of claim 16, further comprising disposing said conduit withinsaid earpiece to align said passage with an external ear canal of saidear.
 18. The method of claim 17, wherein said conduit maintains saidpassage adapted for releasable retention of said in-ear device inrelation to said earpiece during reconfiguration of said externalsurface in said moldable condition of said earpiece.
 19. The method ofclaim 18, further comprises forming said earpiece from a material whichmaintains said first fixed configuration and said second fixedconfiguration at a temperature below about 40° C. (110° F.) andmaintains said moldable condition at a temperature of between about 40°C. (about 110° F.) and about 65° C. (150° F.).
 20. The method of claim19, further comprising forming said earpiece from an amount ofpolycaprolactone polymer having a number average molecular weight in therange of about 37,000 grams per mole and about 80,000 grams per mole.21. The method of claim 20, further comprising configuring said passagefor releasable retention of said in-ear device selected from the groupconsisting of: earphones, earplugs, earbuds, ear tips, and in earhearing aids.
 22. The method of claim 21, wherein said in-ear device isa part of an apparatus which resides outside of said ear.
 23. The methodof claim 22, wherein said apparatus is selected from the groupconsisting of: headsets, head phones, telephones, blue tooth headphones,wireless headphones, and hearing aids.
 24. The method of claim 18,further comprising providing an in-ear device, said in ear devicereleasably retained in said passage with a portion of said in ear deviceconfigured to extend into an ear canal of said ear.
 25. The method ofclaim 24, further comprising providing an earplug adapted for couplingto said portion of said in-ear device configured to extend into saidexternal ear canal of said ear, said earplug having an earplug externalsurface configured to engage an ear canal wall defining said ear canal.26. The method of claim 25, wherein said earplug further comprises: anelongate tubular core defining an earplug passage through which saidportion of said in-ear device extending into said ear canal passes; anda sound attenuating portion directly connected to said elongate tubularcore, said sound attenuating portion configured to conformably engagesaid ear canal wall of said ear.
 27. The method of claim 26, whereinsaid sound attenuating portion further comprises at least one flexibleconvex annular member having an internal concentric edgecircumferentially joined to said elongate tubular core, said flexibleconvex annular member outwardly radially extending from said elongatetubular core to terminate at an external concentric edge.
 28. Themoldable earpiece of claim 27, wherein said a least one flexible convexmember comprises a pair of flexible convex annular members each havingan internal concentric edge circumferentially joined in spaced apartrelation along said elongate tubular core, said pair of flexible convexannular members each outwardly radially extending from said elongatetubular core to terminate at a corresponding pair of external concentricedges, a first of said pair of external concentric edges having lesserdiameter than said second of said pair of external concentric edges.29-46. (canceled)